Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07433699

Image-Guided DBS Programming

The objective of this study is to compare the effects of image-guided programming algorithm using various image segmentations vs standard clinical programming on reduction of tremor and patient satisfaction.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neurosurgery Department Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location contact

Gabriella R Maze, BS

CONTACT

[email protected]

215-829-6720

About this study

At your first visit (Visit 1), your DBS device will be temporarily switched off. The study team will then perform a baseline tremor assessment, utilizing the standard methods of an accelerometer (a device to measure acceleration of movement) and the Clinical Rating Scale for Tremor (CRST). A qualify of life assessment will also be administered using the standard Quality of Life in Essential Tremor (QUEST) questionnaire. Your device will first be programmed with either the image-guided programming settings or the clinical-based programming settings. Then, it will be switched to the other setting after tremor assessments are completed. Under each setting, you will repeat the tremor assessments via accelerometer and the CRST. This will total three tremor assessments during the visit - one for baseline, one for the first setting, and one for the second setting.

After Visit 1, we will set your device to one of the programming settings (either image-guided or clinical-based) at random ("Program A"). You will be on this setting for one week, and then we will call you (Phone Call 1) and ask you to switch to the other setting ("Program B") for one week. After this second week, we will call you again (Phone Call 2) and ask which setting you prefer. At that time, you will be free to utilize the setting you preferred for the next two weeks. You will then come in for your Visit 2 after four total weeks (Program A for one week, Program B for one week, and your preferred setting for two weeks).

At Visit 2, we will evaluate the outcomes of your programming optimization. The tremor assessments will be performed again (accelerometer and CRST). The quality-of-life assessment (QUEST) will be administered as well. We will also capture your impression of change and overall level of satisfaction using the Patient Global Impression of Change (PGIC) scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients from 21-85 years of age
  • ET patients implanted with Boston Scientific DBS electrodes in the VIM thalamus
  • Proficiency with the English Language
  • Participant is able to comply with all testing and follow-up requirements as defined by the study protocol
  • Participant is able to provide voluntary decisionally capable, and appropriately informed consent

Exclusion criteria

• Vulnerable populations such as children, pregnant women, or prisoners Patient is unwilling or unable to provide consent

-

Treatment and study plan

programming a

Device

clinical based programming parameters

programming b

Device

image-guided programming parameters

Primary outcomes

  1. Tremor severity as measured by accelerometry

    Time frame: 1 Month

    • The Xsens MTw Awinda accelerometer will be used to measure tremor severity. Measurements will be taken at baseline (DBS off) and after each stimulation setting. The accelerometry data can be objectively measured by quantifying the frequency and amplitude of the tremors and has been shown to correlate with the CRST.

Secondary outcomes

  1. Clinical measure of tremor severity - CRST

    Time frame: 1 month

    Clinical measure of tremor severity - CRST

Other outcomes

  1. 3. Patient Global Impression of Change (PGIC) Scale

    Time frame: 1 month

    PGIC is a 7-point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse.

  2. 4. Quality of Life in Essential Tremor Questionnaire (QUEST)

    Time frame: 1 month

    The Quality of Life in Essential Tremor Questionnaire (QUEST) is a 30-item scale developed for patients with ET to measure the impact of ET on perceived quality of life (QOL), including activities of daily living that are affected by ET, such as the ability to read and write. The 30 items contribute to five scales: Physical/ADL, Psychosocial, Communication, Hobbies/Leisure, and Work/Finances. The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella R Maze, BS

CONTACT

[email protected]

215-829-6720

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.